FDA applicant

Med-Sonics Corp.

Erie, PA3 decisions2012–20160 recalls

FDA records 3 decisions for Med-Sonics Corp. (Erie, PA) from 2012 to 2016: 3 510(k) clearances. All are in product code FFK (Lithotriptor, Electro-Hydraulic). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Med-Sonics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2012high 2 (2016) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Med-Sonics Corp. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Med-Sonics Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Med-Sonics Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?